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Managing Medication-induced Constipation in Cancer: A Clinical Trial

This study is currently recruiting participants.
Verified March 2013 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of South Florida
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01416909
First received: August 11, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this research is to evaluate the effectiveness of the Constipation Treatment Protocol and to test whether management according to dose of constipation-inducing medications or according to on-going assessment is most effective.


Condition Intervention Phase
Constipation
 Other: Opioid Dose Intervention
Other: Opioid Assessment Intervention
Other: Vinca Alkaloid Assessment Intervention
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Managing Medication-induced Constipation in Cancer: A Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Constipation
U.S. FDA Resources

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Phase I - Record of Each Participant's Constipation Incidents and Their Corresponding Opioid Dose [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Relationship Between Constipation Intensity and Opioid Dose. To identify the incidence, severity, distress and trajectory of constipation in cancer patients receiving opioids over an 8 week period and to evaluate the relationships between constipation intensity and opioid dose.

  • Phase I - Record of Each Participant's Constipation Intensity and Their Vinca Alkaloid Dose [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Relationship Between Constipation Intensity and Vinca Alkaloid Dose. To identify the incidence, severity, distress and trajectory of constipation in groups of cancer patients who may be at risk due to vinca alkaloids over an 8 week period and to evaluate the relationship between intensity and vinca alkaloid dose.


Secondary Outcome Measures:
  • Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation [ Time Frame: 2 years, 3 months ] [ Designated as safety issue: No ]
    To test the efficacy of a Constipation Treatment Protocol in patients with medication-induced constipation.

  • Phase II - Number of Participants With Desired Determination of Dose - Ongoing Assessment Group [ Time Frame: 2 years, 3 months ] [ Designated as safety issue: No ]
    Best Determination of Laxative Dose for Opioid Group. To test whether laxative dose is best determined based on on-going assessment or on opioid dose.

  • Phase II - Number of Participants With Desired Determination of Dose - Opioid Dose Group [ Time Frame: 2 years, 3 months ] [ Designated as safety issue: No ]
    Best Determination of Laxative Dose for Opioid Group. To test whether laxative dose is best determined based on on-going assessment or on opioid dose.


Estimated Enrollment: 875
Study Start Date: November 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Opioid Dose Intervention Group
Patients Receiving Opioids for the Treatment of Pain
 Other: Opioid Dose Intervention
Patients will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be based on the dose of the opioid pain medication that they are receiving. The oncology nurse will work with the patient to be sure that the protocol is fully understood.
Active Comparator: Opioid Assessment Intervention Group
Patients Receiving Opioids for the Treatment of Pain
 Other: Opioid Assessment Intervention
Patients will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of the laxative will be determined based on the severity of their constipation. The oncology nurse will work with the patient to be sure that the protocol is fully understood.
No Intervention: Opioid Control Group
Patients Receiving Opioids for the Treatment of Pain will receive their usual care at Moffitt while participating in weekly assessments.
Active Comparator: Vinca Alkaloid Assessment Intervention Group
Patients Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine.
 Other: Vinca Alkaloid Assessment Intervention
The patient will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of the laxative will be based on their level of constipation. The oncology nurse will work with the patient to be sure that the protocol is fully understood.
No Intervention: Vinca Alkaloid Control Group
Patients Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. Patients will receive standard of care while participating in weekly assessments.

Detailed Description:

Patients will undergo a baseline assessment during their regular outpatient visit. With their permission, the investigators will audio record this visit for quality control. After the study, the recordings will be erased. Patients will be asked to complete 4 questionnaires. The investigators will collect contact information so that the follow-up assessments can be done by phone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study sample will consist of patients who are receiving outpatient care at the Moffitt Cancer Center.
  • Patients will be identified as those who have a diagnosis of cancer and are being treated with either opioids or vinca alkaloids,
  • are adults (or children 18-21 years old),
  • either male or female,
  • able to read and understand English,
  • and able to pass screening with the Short Portable Mental Status Questionnaire and Karnofsky Performance Status Scale.

Exclusion Criteria:

  • Patients will be excluded: if they have non-melanoma skin cancer or colorectal or gynecological cancer as their primary diagnosis;
  • if they are excessively debilitated or deemed unlikely to survive for the eight weeks of the data collection period;
  • if they are unable to read and understand English;
  • if they have an ostomy that changes bowel function;
  • if they have a current peritoneal catheter;
  • if they have had abdominal surgery within the past six weeks;
  • or have a disease process suggestive of mechanical obstruction (tumor or adhesion);
  • if they have a history of chronic bowel disease (including irritable bowel syndrome, chronic constipation prior to cancer onset, Crohn's disease, ulcerative colitis or diarrhea as a result of radiation to the pelvis), or report chronic laxative use prior to cancer onset.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416909

Contacts
Contact: Susan McMillan, Ph.D., RN 813-745-9188 smcmilla@health.usf.edu

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Amy Franklin     813-745-1841     amy.franklin@moffitt.org    
Principal Investigator: Susan McMillan, Ph.D., RN            
Sub-Investigator: David Craig, PharmD            
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Institutes of Health (NIH)
University of South Florida
Investigators
Principal Investigator: Susan McMillan, Ph.D., RN University of South Florida
  More Information

Additional Information:
Moffitt Cancer Center Clinical Trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01416909     History of Changes
Other Study ID Numbers: MCC-15712
Study First Received: August 11, 2011
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Medication-induced
Constipation in Cancer

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Vinca Alkaloids
Analgesics, Opioid
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 18, 2013